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Hormone Therapy

Leuprolide Oral Tablet - 120 mg - QD- Treatment A for Endometriosis

Phase 2
Waitlist Available
Research Sponsored by Enteris BioPharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment days: 1,8, 15, 22 and 29; post dosing day 14
Awards & highlights

Study Summary

This study is evaluating whether a drug can suppress estrogen levels in women.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment days: 1,8, 15, 22 and 29; post dosing day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment days: 1,8, 15, 22 and 29; post dosing day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL
Secondary outcome measures
(Pre-dose leuprolide level) Subject incidence of Leuprolide below detectable level
Composite Pelvic Signs and Symptoms (CPSS) scores
Follicle Stimulating Hormone (FSH) levels
+3 more

Side effects data

From 2019 Phase 4 trial • 107 Patients • NCT03035032
17%
Prostatic specific antigen increased
9%
Cough
8%
Back pain
8%
Hot flush
6%
Anaemia
6%
Upper respiratory tract infection
4%
Pneumonia
3%
Death
2%
Neuralgia
2%
Arthralgia
2%
Haemorrhage intracranial
1%
Muscular weakness
1%
Epistaxis
1%
Fluid overload
1%
Prostate cancer metastatic
1%
Headache
1%
Dementia
1%
Deep vein thrombosis
1%
Dyspnoea
1%
Pain in extremity
1%
Chronic obstructive pulmonary disease
1%
Musculoskeletal chest pain
1%
Hyperglycaemia
1%
Syncope
1%
Pleural effusion
1%
Dysuria
1%
Septic shock
1%
Viral upper respiratory tract infection
1%
Femur fracture
1%
Spinal compression fracture
1%
Weight decreased
1%
Cardiac failure congestive
1%
Abdominal wall haematoma
1%
Anal hypoaesthesia
1%
Incarcerated inguinal hernia
1%
Inguinal hernia
1%
Inguinal hernia, obstructive
1%
Pancreatitis
1%
Proctalgia
1%
Vomiting
1%
Multiple organ dysfunction syndrome
1%
Peripheral swelling
1%
Appendicitis
1%
Gastroenteritis
1%
Sepsis
1%
Spinal cord compression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprolide Acetate 22.5 mg

Trial Design

5Treatment groups
Experimental Treatment
Group I: Treatment E:Leuprolide Oral Tablet (Ovarest), 40 mg BIDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 40 mg, administered twice daily (BID), 12 hours apart for up to 29 consecutive days with food-intake restrictions.
Group II: Treatment D: Leuprolide Oral Tablet, 60 mg BIDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 60 mg, administered twice daily (BID), 12 hours apart for up to 35 consecutive days with food-intake restrictions.
Group III: Treatment C: Leuprolide Oral Tablet, 60 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 60 mg, administered once daily (QD) for up to 29 consecutive days with food-intake restrictions.
Group IV: Treatment B: Leuprolide Oral Tablet, 80 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 80 mg (2 x 40 mg tablets), administered once daily (QD) for up to 35 consecutive days with food-intake restrictions.
Group V: Treatment A: Leuprolide Oral Tablet, 120 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 120 mg (2 x 60 mg tablets), administered once daily (QD), for up to 35 consecutive days with food-intake restrictions.

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
304 Previous Clinical Trials
101,136 Total Patients Enrolled
Enteris BioPharma Inc.Lead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Endometriosis
35 Patients Enrolled for Endometriosis
Syneos HealthOTHER
172 Previous Clinical Trials
68,438 Total Patients Enrolled
1 Trials studying Endometriosis
35 Patients Enrolled for Endometriosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis
2022. "Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05096065.
All > Endometriosis
~5 spots leftby May 2025
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